Federal mandates exist from both NIH and FDA on including children in clinical research. However, when and how to include children, particularly in clinical trials, is highly debated. Concerns are particularly heightened when: Children have life-threatening conditions There is little time to make this decision

Parents / legal guardians give permission for their children to participate in research. Older children (~>7yrs.) are asked to give assent.

Much of the previous research related to parents’ decision making around children’s participation in research has been conducted separately in the contexts of pediatric cancer, surgery or neonatology.

There are many barriers to informed permission / consent when parents are asked to make decisions about their child’s participation in research: Time constraints Complicated research protocols Inadequate understanding Stress imposed by child’s condition Less than ideal communication

Background

Parent Decision Making in Pediatric Research Denise B. Angst, PhD, RN*; Emily Hadley, MS, RN*; Bryan Coyle, MA#

Advocate Center for Pediatric Research*; Advocate IRB#

Parent Decision Making in Pediatric Research Denise B. Angst, PhD, RN*; Emily Hadley, MS, RN*; Bryan Coyle, MA#

Advocate Center for Pediatric Research*; Advocate IRB#

SampleAny parent who enrolled or declined enrollment of their child in

a clinical research study at AHCH or ALGCHApproached within 12 weeks of the original studyEnglish-speaking

MeasurementsDemographic and Decision Making Supplement

31 items, evaluating parent and child demographics; perception of research risks and benefits, previous experience with research, decision making process

Parent Decision Making (DM) Survey Based loosely on survey by Tait et al. 65 items were reviewed by 5 content experts Final tool was 70 items, each item with a 5-point Likert scale

(1 strongly disagree – 5 strongly agree), organized in 11 themes/domains

Data AnalysisDescriptive statistics; t-tests to compare subgroupsReliabilities and correlational analyses to evaluate DM survey

Conclusions

ResultsMethods

Specific Aims1) Examine parents’ decision making regarding their

children’s research participation across various illness and other contexts

2) To develop and evaluate an instrument that could be used across pediatric conditions and decision making contexts.

Results

Results These results are most representative of parents who decide to enroll (vs. decline enrollment), and only represent some of our preliminary analyses to date

The vast majority of parents are making this decision in a very short period of time (75% <1 day)

Fewer parental resources (education, SES) may make it more difficult for them to decline

Features that distinguish those who enroll vs. decline appear consistent with prior research: Beliefs in benefits for their child and other children Beliefs in the importance of research Perception of risks

Compared to other conditions, parents of children with cancer see the research as benefiting their child and see their child’s condition as more serious

Decision making tool results are highly preliminary, given sample size. Tool shows some promise, but needs further evaluation when additional parents have been enrolled

Enrolled N = 55 (n, %)

Declined N = 14 (n, %)

All Parents N = 69 (n, %)

Child’s Condition Oncology Neonatology Other Chronic Condition

32 (58) 15 (27) 8 (15)

1 (7)9 (64)4 (29)

33 (48) 24 (35) 12 (17)

Child’s Age < 1 month 2-10 years 11-17 years

13 (34)13 (34)12 (32)

11 (92)1 (8)

0

24 (48)14 (28)12 (24)

Parent’s Highest Education High school grad Some college > College grad

10 (18) 15 (27) 30 (55)

1 (7)2 (14)

11 (79)

11 (16) 17 (25) 41 (59)

Race/ Ethnicity Caucasian African American Other

42 (76) 6 (11) 7 (13)

13 (93)0

1 (7)

55 (80) 6 (9) 8 (11)

Annual Household Income < $50k $50k - 89,999 ≥ 90k

17 (32) 16 (29)

20 (38)

0 5 (36)9 (64)

17 (25)

21 (30)

29 (42)

Table 1. Sample Characteristics: Enrolled vs. Declined

Table 2. Selected DM Survey Item Responses

EnrolledN = 55

(mean, SD)

DeclinedN = 14

(mean, SD)

p-value

Perception of Seriousness of Child’s Condition (1=mild, 10 = severe)

7.2 (2.5) 7.2 (2.2) .96

Benefit for Child (1=no benefit, 10 = extremely beneficial)

6.1 (3.0) 2.5 (2.1) .0001

Benefit for Other Children (1=no benefit, 10 = extremely beneficial)

8.4 (2.2) 6.2 (2.0) .002

Perception of Risk (1=no risk, 10 = extremely risky)

3.4 (2.3) 6.4 (2.6) .0002

Importance of Research (1=not impt., 10 = extremely impt.)

8.6 (2.0) 6.2 (1.6) .0002

Table 3. Parent Perceptions: Enrolled vs. Declined

Parents of Children with Cancer vs. Other Conditions

Decision Making Survey Based on analysis of first 50 parents 2-3 domains / scales appear to have subscales Internal consistency: = 0.41-0.87; 7 scales with >0.74 Discrimination: Enrolled vs. Declined

Most scales did not discriminate based on participation

3 scales showed differences: Decisional Uncertainty, Influence of Child’s Condition, View of Study

Discrimination: Diagnostic Groups Oncology vs. NICU vs. Other Chronic Condition 6 scales appear to differentiate groups: Quality of

Consent Process-1, Quality of Consent Process-2, View of Study, Other Decisional Influences, Trust / Relationship with Dr. / Staff, Quality of Consent Form

AcknowledgementsThanks to the research coordinators and clinical staff who assisted in recruiting parents: Ramona Donovan, Rina DiMaso, Bonnie Hughes, Suellen Moen, Lorene Schweig, Regina Schwartz, and Jane Suszek.

Next Steps Parents are continuing to be enrolled; goal N=100 parents

Advocate Hope Children’s Hospital

Advocate Lutheran General Children’s HospitalParent Decision Making in Pediatric Research

Denise B. Angst, PhD, RN*; Emily Hadley, MS, RN*; Bryan Coyle, MA#

Advocate Center for Pediatric Research*; Advocate IRB#

Parent Decision Making in Pediatric Research Denise B. Angst, PhD, RN*; Emily Hadley, MS, RN*; Bryan Coyle, MA#

Advocate Center for Pediatric Research*; Advocate IRB#

Compared to parents of children with other conditions, parents of children with cancer viewed,

Their child’s condition as more serious (8.2 vs. 6.3; p=0.002) The research as more important (6.8 vs. 4.1; p=0.0005) The research as benefiting their child (8.8 vs. 7.5; p=0.01)

However, there were no statistically significant differences in their perception of study risks (4.1 vs. 3.9; p=0.68)

Enrolled N = 55

(n, % Agreed or Strongly Agreed)

Declined N = 14

(n, % Agreed or Strongly Agreed)

p-value

Altruism

Participating in Research will Help Other Children 53 (96) 12 (86) 0.18

Decisional Uncertainty

Wanted Study Doctor to Advise me on Decision 14 (26)* 2 (14) 0.49

Child Influences

Would Participate in Any Study to Benefit Child 44 (81)# 4 (29) 0.0003

Study Characteristics

Study Seemed Very Risky 2 (4) 7 (50) 0.001

Trust / Relationship with Dr. and Staff

Study Wouldn’t have been Offered unless Beneficial 36 (65) 5 (36) 0.07

Understanding

I Understood What was Required 46 (84) 9 (64) 0.14

Quality of Permission / Consent Process

Had Enough Time to Make Decision 43 (78) 8 (57) 0.17

Satisfaction with Decision Making

Make Same Decision Again 44 (81) # 13 (93) 0.44

Parents completed DM supplement and survey at a median of 7 days from their decision making regarding the original research.

75% parents made their decision re: the original study in < 1day.

*N = 53 # N = 54